FDA Adverse Event
Malfunction
Summary report: N
DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
MDR report key: 17520646
·
Received August 12, 2023
Report
- Report Number
- MW5127594
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- October 17, 2018
- Manufacturer
- ST. JUDE MEDICAL
- Product Code
- NVN
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
THIS RV LEAD WAS IMPLANTED ON (B)(4) AND REMAINS IMPLANTED AS OF THIS TIME. A CALL WAS PLACED TO TECHNICAL SERVICES ON 04/25/2006 STATING THAT THIS LEAD HAD MORE THAN 2000 OHMS. NOISE WAS NOTED ON THE RV LEAD FOLLOWING THE LEAD SAFETY SWITCH. THE FOLLOWING PHYSICIAN WAS DR. (B)(6). NO OTHER INFORMATION IS AVAILABLE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2182164 | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | ST. JUDE MEDICAL | 1688TC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |